Health Tech Podcast - Episode 3: HIPAA, HITECH and TCPA
The Biggest Changes in HIPAA/HITECH Omnibus Rule & Recommended Action Steps—Ted Kobus
AI tools often drive efficiency and save money, but they have drawbacks. Here’s what to know....more
Healthcare organizations continue to be prime targets of cyberattacks. It is well-established that cyberattacks can lead to financial loss, reputational damage, and, in some cases, risks to patient care and safety. The recent...more
Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more
There has been a notable emphasis on proactive enforcement of the privacy and security of protected health information in recent weeks as evidenced by multiple developments regarding compliance with the Health Insurance...more
Updates to the Health Insurance Portability and Accountability Act Security Rule (“HIPAA Security Rule”) are planned for Spring 2024. New guidance from The Department of Health and Human Services (“HHS”) via a recently...more
The U.S. Department of Health and Human Services ("HHS") issued a concept paper describing its overarching strategy to address healthcare cybersecurity. The concept paper builds on the Biden-Harris Administration's National...more
Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
On February 1, 2023, the Federal Trade Commission (FTC) announced that it had taken enforcement action against prescription drug discount company GoodRx, which agreed to injunctive relief and to pay a $1.5 million civil...more
Much is being written about “remote work” – is it productive, will demand for it continue or be curtailed in a recession, is cybersecurity compromised, does it inhibit workplace culture, collaboration, etc. Lots of questions,...more
A strong cybersecurity program can help defend against cyber attacks and protect sensitive patient data. Thanks to a 2021 amendment of the HITECH Act, when a breach occurs, it can also reduce enforcement penalties. The...more
Report on Patient Privacy 22, no. 5 (May, 2022) - Compared to other agencies, the HHS Office for Civil Rights (OCR) is a little fish in the big federal pond, but it has an outsize effect on HIPAA covered entities (CEs) and...more
The Department of Health and Human Services (“HHS”) has issued a formal request for information from the public about how regulated entities are implementing industry recognized security practices. The request for information...more
Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...more
Enforcement Actions - In its first announcement of enforcement actions in 2022, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) simultaneously announced the resolution of three...more
Earlier this month, HHS’s Office for Civil Rights (OCR) issued a Request for Information (RFI) seeking comments on a statutory provision adopted last year that provides a quasi-safe harbor for entities that have voluntarily...more
The US Department of Health Human Services (HHS) is seeking public comments about the appropriate role of “recognized security practices” in enforcement of the HIPAA Security Rule. Congress, through an amendment to the HITECH...more
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released a Request for Information (RFI) to obtain industry feedback and inform potential future rulemaking regarding information...more
On April 4, 2022, the U.S. Department of Health and Human Services (HHS) released a Request for Information (RFI) seeking input from HIPAA-covered entities and business associates on how the industry understands and is...more
War in the Time of Crypto - "In the Russia-Ukraine conflict, which side is crypto helping? Both." Why this is important: The world continues to watch Russia's invasion of Ukraine as it dominates news outlets. An...more
Over the last several months, a minority of states amended their data breach notification statutes or enacted sector-specific breach notification requirements. ...more
On October 1, 2021, two Acts overhauling data privacy and cybersecurity in Connecticut took effect—the latest instance of stronger state breach reporting requirements with a safe harbor protection from litigation for...more
An amendment to the Health Information Technology for Economic and Clinical Health (HITECH) Act was signed into law on Jan. 5, 2021, directing U.S. Health and Human Services (HHS) to consider "recognized security practices"...more
Connecticut Governor Ned Lamont recently signed into law “An Act Incentivizing the Adoption of Cybersecurity Standards for Businesses” (Public Act No. 21-119). Under the Act, “covered entities” that implement certain...more
Connecticut recently enacted cybersecurity legislation that provides a safe harbor for businesses that implement a written cybersecurity program. Under the legislation, set to go in effect on October 1, 2021, punitive damages...more
Introduction - The Connecticut legislature recently enacted a pair of new data breach and cybersecurity statutes — Public Act 21-59 and Public Act 21-119 — on June 16 and July 6, respectively. Both laws will take effect on...more